Response to Clenbuterol in Humans

• Sponsor: University of Copenhagen (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT03860870
• Collaborator: (none)
• Enrollment: 16
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 36.1
• Patients Per Site Per Month: 0.4

Study Details

Study Description

Brief Summary

Due to the long half-life (~36 hr) of clenbuterol, detection methods such as dried blood spots (DBS) are a potentially suitable method to easily and non-invasively detect doping misuse of this compound for several days after ingestion. If, and how long, the compound can be detected by DBS has not yet been investigated but is of interest due to its potential in doping-control. The aim is to evaluate whether abuse of clenbuterol can be detected at relevant concentration levels in samples obtained using DBS and to assess the physiological response to clenbuterol in skeletal muscle..

Condition or Disease	Intervention/Treatment	Phase
Healthy	Drug: Clenbuterol Oral Product; Drug: Placebo	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 16 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Intervention Model Description: Two phases: First phase sequential Second phase crossoverTwo phases:First phase sequential Second phase crossover
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Masking Description: First phase - open label Second phase - double-blinded
• Primary Purpose: Basic Science
• Official Title: Detectability of Clenbuterol and Physiological Response in Human Skeletal Muscle
• Actual Study Start Date: Mar 11, 2019
• Anticipated Primary Completion Date: Mar 15, 2022
• Anticipated Study Completion Date: Mar 15, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Clenbuterol Subjects ingest 80 micrograms of clenbuterol tablets	Drug: Clenbuterol Oral Product; Subjects ingest 4x20 microgram clenbuterol tablets
Placebo Comparator: Placebo Subjects ingest placebo tablets	Drug: Placebo; Subjects ingest placebo tablets

Outcome Measures

Primary Outcome Measures

1. Blood clenbuterol concentration [Before (baseline) as well as 3, 8, 24, 72, 168 and 240 hours after administration of clenbuterol]

   Concentration of clenbuterol in dried blood spots

Secondary Outcome Measures

1. Blood clenbuterol concentration [Before (baseline) as well as 3, 8, 24, 72, 168 and 240 hours after administration of study drug]

   Concentration of clenbuterol in venous blood

2. Urine clenbuterol concentration [Before (baseline) as well as 3, 8, 24, 72, 168 and 240 hours after administration of study drug]

   Concentration of clenbuterol in urine

3. Muscle strength [Before (baseline) and 2.5 hours after administration of study drug]

   Maximal voluntary isometric contraction in N/m2 of the quadriceps

4. Muscle signalling [Before (baseline) and 2.5 hours after administration of study drug]

   Protein kinase A phosphorylation in vastus lateralis biopsies

5. Plasma K+ [Before (baseline) as well as 2.5 hours after administration of study drug]

   Venous plasma K+ concentration

6. Muscle mTOR signalling [Before (baseline) as well as 2.5 hours after administration of study drug]

   mTOR phosphorylation in vastus lateralis biopsies

7. Metabolic rate [Before (baseline) as well as 2.5 hours after administration of study drug]

   Respriatory exchange ratio of oxygen and CO2

8. Maximal voluntary strength [Before (baseline) and after two-week treatment of study drug]

   Maximal voluntary isometric muscle strength of the quadriceps

9. Body composition [Before (baseline) and after two-week treatment of study drug]

   Lean and fat mass during a DXA-scan

10. Aerobic capacity [Before (baseline) and after two-week treatment of study drug]

    Maximal oxygen uptake during maximal exercise

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 40 Years
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Healthy

• Male

• 18-40 years of age

• No known contraindications for anabolic drugs (e.g. cancer)

Exclusion Criteria:

• Abnormal ECG

• Steroid abuse

• Ongoing use of prescription medication

• heavy resistance training more than 2 times weekly

• Disease deemed by the MD to infer a risk to participate in the trial

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	August Krogh Building	Copenhagen		Denmark

Sponsors and Collaborators

• University of Copenhagen

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Morten Hostrup, PhD, Associate Professor, University of Copenhagen
• ClinicalTrials.gov Identifier: NCT03860870
• Other Study ID Numbers: CLEN
• First Posted: Mar 4, 2019
• Last Update Posted: May 3, 2021
• Last Verified: Apr 1, 2021

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Morten Hostrup, PhD, Associate Professor, University of Copenhagen: dried blood spots; skeletal muscle biopsies; muscle strength; muscle signaling
• Additional relevant MeSH terms: Clenbuterol

Study Results

No Results Posted as of May 3, 2021